FDA.reportPublic FDA data

NDC 49825-129-01 - Breakout Control Bioelements

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49825-129
Requested NDC
49825-129-01
Package NDCs from labels
49825-129-01, 49825-129-02
Manufacturer
Bioelements, Inc.
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Breakout ControlBioelements, Inc.2024-07-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-129-022024-08-27C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control
49825-129-022024-01-30C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-129BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]8Legacy NDC20240829_3546feee-7568-4b58-bb32-3dfcda7da694.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8IBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
SQUALANEINACTIVE INGREDIENTGW89575KF9BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 66 · 1,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact identifier
application number: M006
AzelaqSALICYLIC ACIDMETHODIQ INC.43084456-e452-07d9-e063-6294a90a36c82025-11-10WarningsExact identifier
application number: M006
DapinaqSALICYLIC ACIDMETHODIQ INC.43417b1a-ff07-32da-e063-6294a90aa9032025-11-10WarningsExact identifier
application number: M006
DuolaqSALICYLIC ACIDMETHODIQ INC.4341d931-897d-c298-e063-6394a90a4d6f2025-11-10WarningsExact identifier
application number: M006
SUPPORT SERUM FORTIFIEDSULFURZENMED Raging Creations Ltd.26e5777d-4ce2-458c-90f1-4c23c7b571ed2025-11-10WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Spot GelSALICYLIC ACIDTHG Beauty USA LLC1f92122d-4873-8c1a-e063-6294a90a1c3b2025-11-07WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Clearing TreatmentSALICYLIC ACIDTHG Beauty USA LLC1f4108da-c83b-4b1d-e063-6294a90abfd72025-11-07WarningsExact identifier
application number: M006
e.l.f Skin Acne-Treating Body MistSALICYLIC ACIDe.l.f. Cosmetics, Incf575b71f-d2bf-7469-e053-2995a90a02eb2025-11-07WarningsExact identifier
application number: M006
Naturium Benzoyl Peroxide Cleanser 5%BENZOYL PEROXIDEe.l.f. Cosmetics, Inc0a278590-e98b-7cab-e063-6394a90a4d0e2025-11-07WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Clear Smart Charcoal Blackhead ScrubSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.5e13ccf6-f66a-475f-aaf8-6609369c36a82025-11-05WarningsExact identifier
application number: M006
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories54ebb0ba-e32c-4b8e-8427-b947ca6441502025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories42e9bea8-e840-4163-929e-967baf5f2f902025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories1ac05b1f-d508-4e9b-bef1-22e522ad740f2025-11-03WarningsExact identifier
application number: M006
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.